ApprovalTrail

Approval · Notice of Compliance 17908 · 2016

ENTYVIO: Notice of Compliance 17908

Issued March 22, 2016

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
17908
Date
March 22, 2016
Company
Takeda Canada IncorporatedToronto, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: for the tereatment of adult patients with moderately to severely active crohn's disease who have had an inadequate respone with, lost response to or were intolerant to a tumor necrosis factor-alpha (tnfa) antagonist or immunomodulators, or had inadequate response, intolerance or demonstrated dependace on corticosteroids

Products in this notice

BrandDINStatus today
ENTYVIONot yet assigned—

Medicinal ingredients